1. Technical Field
The embodiments herein generally relate to the field of molecular nanotechnology. The embodiments herein particularly relate to nanomedicines or nanocarrier based drug delivery systems. The embodiments herein more particularly relate to a system and method for synthesizing long acting, and slow release nanoparticle or nano carrier based drug delivery system for Insulin.
2. Description of the Related Art
In nanotechnology, a particle is defined as a small object that becomes a whole unit with respect to its transport and properties. The particles are further classified according to the diameter. The “nanoparticles” have a diameter within a range of 1 and 100 nanometer.
Nanotechnology has offered many advantages for novel drug delivery systems in terms of both time-controlled drug delivery and site-directed drug delivery. These advantages are mainly derived from the very small (submicron) sizes of the nanostructures used as nanocarriers for drugs as well as the possibility of engineering the carrier structure and/or surface according to the particular biological requirements.
“Nanomedicine” is the medical application of nanotechnology. Nanomedicine ranges from the medical applications of nonmaterial's to nano-electronic biosensor and even possible future applications of molecular nanotechnology.
The current problems for nano-medicine involve understanding the issues related to toxicity and the environmental impact on a nanoscale material.
The nano-medicine has provided the possibility of delivering drugs to specific cells using nanoparticles. The overall drug consumption and side effects are lowered significantly by depositing an active agent only in a morbid region at a required and appropriate dosage thereby eliminating a need for a higher dosage.
Drug delivery researchers are developing nanoscale particles or molecules to improve a “bioavailability” of a drug. The term bioavailability refers to the presence of drug molecules where they are used in the body and where they act against an ailment. Drug delivery system mainly focuses on maximizing the bioavailability both at specific places in the body and over a period of time.
The drug delivery systems such as lipid or polymer based nanoparticles are designed to improve the pharmacological and therapeutic properties of the drugs. Further, the metal based nanoparticles are also designed and developed to deliver the drugs.
The commonly used metals for nano-drug delivery system include but not limited to gold, silver, platinum etc. The metal based nanoparticles for the drug delivery system show toxicity. The recent studies in this arena have shown that positively charged gold nanoparticles are found to enter kidney, while negatively charged gold nanoparticles remained in the liver and spleen. The positive surface charges of the nanoparticles decreases the rate of opsonization of nanoparticles in the liver, thereby affecting the excretory pathway. Even a relatively small size of the nanoparticles such as 5 nm can become compartmentalized in the perinephral tissues, and accumulate in the body over tissues. The advancement of research proves that targeting and distribution can be augmented by nanoparticles and the dangers of nano-toxicity have become an important question for the medical use in drug delivery.
A drug may cause tissue damage, but a drug delivery with regulated drug release can eliminate the problem. When a drug is removed too quickly from the body, this rapid drug delivery could force a patient to use a dose higher than a necessary dose. But a clearance can be reduced with drug delivery systems by altering the pharmacokinetics of the drug. A poor bio-distribution is a problem that can affect normal tissues through a widespread drug distribution, but the particulates from the drug delivery systems lower the volume of distribution and release the effect on a non-target tissue. The potential nano-drugs works by very specific and well understood mechanisms, one of the major impacts of nanotechnology and nano-science is the development of completely new drug delivery systems with more useful behaviors and less side effects.
Long-acting injectable drug delivery systems can benefit from the potentials of nanotechnology via the slow drug release from the nano-carriers already being loaded by the drug of interest. These drug carriers may be administered by injection into the host body through different routes mainly including intravenous, intramuscular, subcutaneous, intra-dermal, intra-arterial, intra-thechal, and intra-cardiac administration. Basically, a drug dose loaded in a nano-carrier is administered and the carrier, then supplies the drug needed for the particular pharmacological effect for a more extended time following a single dose compared to a conventional bolus dose. The pharmacokinetic outcome of the injectable long-acting dosage form is expected to be the lack of fluctuations in plasma concentrations of the drug which, eventually, results in avoiding the risks of over dosages, i.e., toxicity, or under dosages, i.e., treatment failure, in drug therapy. When a particular drug is administered in a chronic (long-term) basis in the form of repeated doses, a fluctuation in drug concentrations in plasma is observed. These pharmacokinetic fluctuations directly result in pharmacodynamic fluctuations where the drug affects the site of action and experiences peaks and troughs at the same time of concentration changes or after a lag phase. These fluctuations in the drug concentration are highly risky for patient, in particular for a drug like methadone with narrow therapeutic index (small differences between therapeutic and toxic doses). With the conventional, currently available products of the drug in the market, there is always a risk for the patient to experience an overdosage (toxic effects in brain or other tissues) in the peak times or an underdosage (insufficient drug effect), both the stages are harmful for the patient.
Diabetes mellitus (DM) is also known as simply diabetes, is a group of metabolic diseases in which high blood sugar levels are present over a prolonged period. The high blood sugar produces the symptoms of frequent urination, increased thirst and increased hunger. The acute complications include diabetic ketoacidosis, and ketotic hyper-osmolar coma. Serious long-term complications of diabetes include heart diseases, stroke, kidney failure, foot ulcer and damage to the eyes. Diabetes is caused when the pancreas does not produce enough insulin, or the cells of the body do not respond properly to the insulin produced. There are 3 types of diabetes mellitus. They are known as Type 1 Diabetes mellitus (DM); Type 2 Diabetes mellitus (DM) and Gestational Diabetes.
Type 1 Diabetes mellitus (DM)—occurs, when the body of a person fails to produce enough insulin. This form is referred to as “insulin dependent diabetes mellitus” (IDDM) or “juvenile diabetes”. Type 2 Diabetes mellitus (DM) begins with insulin resistance, a condition in which cells fail to respond to insulin properly. As the disease progresses a lack of insulin may also develop. This is referred to as non-insulin dependent diabetes mellitus (NIDDM). Gestational diabetes is the third main form of diabetes. It occurs when pregnant women without a previous history of diabetes develop a high blood glucose level.
The diabetes is managed by diet regime, medications (such as metformin), pancreatic transplantation and stem cell therapy to restore pancreatic function. Type 1 diabetes is typically treated with a combination of regular NPH insulin or synthetic insulin analogs. Insulin used in type 2 diabetes, a long acting formulation is usually added initially while continuing oral medications.
The major problem for the patients requiring external insulin is the right dose of insulin and the right timing of administration. The symptoms of low blood sugar levels that are brought on by an insulin overdose include anxiety, confusion, extreme hunger, fatigue, irritability, sweating or clammy skin, trembling hands. The prolonged use of insulin overdose may lead to protein accumulation in kidney resulting in renal failure.
The formulation of a long-acting product form of insulin has a potential to improve the condition of diabetic patient. The potential of insulin nanocarrier is testified by the long acting nature, slow and controlled release of the insulin from the nanocarrier. The lipid based as well as polymeric-based nanoparticles are prepared and loaded with the drug insulin which upon entry to the host body via injection serves as a drug reservoir. The insulin reservoir is capable of releasing the insulin drug for long time periods in blood circulation. This long-term drug profile is used as a basis for prolonged chronic drug action toward the desired effects against diabetes. The fluctuations in the drug like insulin have negative impact on the blood glucose levels.
Hence there is a need to develop a nanoparticle based drug delivery system for insulin without any threat of cytotoxicity. Also there is a need for a nanoparticle drug delivery system for insulin to release the drug slowly and in a controlled manner to an action site. Further there is a need to develop a method for synthesizing the organic biomolecule based nanoparticle drug delivery system for insulin.
The above mentioned shortcomings, disadvantages and problems are addressed herein and which will be understood by reading and studying the following specification.